# K013648: Viabahn Endoprosthesis

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jan 8, 2002 after 64 days
- Product code: JCT (Prosthesis, Tracheal, Expandable)
- Device class: 2
- Regulation: 21 CFR 878.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ultraflex™ Tracheobronchial Stent System: named in the summary without a submission number
- (no number) WALLSTENT® Tracheobronchial Endoprosthesis: named in the summary without a submission number
- (no number) aSpire Covered Stent and Delivery Catheter: named in the summary without a submission number

## Most influential descendants
- K093934: Gore Hybrid Vascular Graft (2010), 0 descendants of its own

## Indications for use
The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

Source page: https://510kreport.com/device/K013648
Methodology: https://510kreport.com/methodology